GAMP® 5

Online Live
Online Live Overview This Virtual course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two-day fundamental course* introduces participants to regulatory requirements for computerized...
iSpeak Blog
Background As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting...
Features
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management...
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GAMP® refers to Good Automated Manufacturing Practice. A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users...
Insights
Ten years after its publication, the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems is regarded as the definitive industry guidance on GxP∗ computerized system compliance and validation for companies and suppliers and is...
Training
GAMP 5 was published in 2008 to great acclaim around the world. Just having the guide published does not mean the benefits it offers will automatically be achieved. This seminar will look at some of the corporate and...
Training
Ever wonder whether your spreadsheet or other desktop application requires validation? This webinar helps you find out by providing deeper understanding for compliant end-user applications and the GAMP 5 Special Interest...
Online Learning Courses
The pharmaceutical industry is responding to the challenge of significantly improving the way drug development and manufacturing is managed. New concepts are being developed and applied, including science-based risk...